Form 483

Versiti Wisconsin, Inc Form 483, 2014-10-03

FDA issued a Form 483 to Versiti Wisconsin, Inc on 2014-10-03 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Versiti Wisconsin, Inc · Wauwatosa, United States · Issued October 3, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Oct 2014
21 CFR 606.100(c)

Thorough investigations

Cited by Michelle J Glembin

Inspected site

VWVersiti Wisconsin, IncWauwatosa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere